AIX1000 Analyzer

Basic Information

• Brand Name: AIX1000 Analyzer
• Primary DI: B35000400R0
• Version / Model: 00400R
• Catalog Number: 00400R
• Company Name: Gold Standard Diagnostics Corporation
• Labeler DUNS: 790524891
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-31
• Public Version: 1
• Public Version Date: 2023-11-08
• Public Version Status: New
• Public Device Record Key: ddb57926-b558-427b-a81e-7eed0262fc7c

Device Description

AIX1000 Rapid Plasma Reagin (RPR) Analyzer (refurbished)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GMQ	Antigens, Nontreponemal, All	Microbiology	866.3820	2

GMDN Terms

Code	Name	Definition	Implantable	Status
51819	Treponema pallidum reagin antibody IVD, kit, agglutination	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of non-specific reagin antibodies that are produced in response to infection with Treponema pallidum bacteria, in a clinical specimen using an agglutination method [for example Rapid Plasma Reagin (RPR) test or Venereal Disease Research Laboratory (VDRL) test]. The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B35000400R0	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K150358	000